The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Rxl Max With Advia Modular Automation System (amas).
| Device ID | K083339 |
| 510k Number | K083339 |
| Device Name: | DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10509 |
| Contact | Lubomyr Shchur |
| Correspondent | Lubomyr Shchur Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10509 |
| Product Code | CIC |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-12 |
| Decision Date | 2009-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596754 | K083339 | 000 |